TAXUS PERSEUS Small Vessel
PERSEUS SV
A Prospective Evaluation in a Non-Randomized Trial of the Safety and Efficacy of the Use of the TAXUS® ElementTM Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions in Small Vessels
2 other identifiers
interventional
224
1 country
28
Brief Summary
The purpose of the TAXUS PERSEUS Small Vessel trial is to evaluate the safety and efficacy of the next-generation Boston Scientific TAXUS paclitaxel-eluting coronary stent system (TAXUS® ElementTM) for the treatment of de novo atherosclerotic lesions of up to 20 mm in length in native coronary arteries of ≥ 2.25 mm to \< 2.75 mm diameter.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 coronary-artery-disease
Started Jul 2007
Longer than P75 for phase_3 coronary-artery-disease
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2007
CompletedFirst Posted
Study publicly available on registry
June 21, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedResults Posted
Study results publicly available
June 28, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedMay 8, 2014
April 1, 2014
1.9 years
June 20, 2007
April 28, 2011
April 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
In-stent Late Loss Measured by Quantitative Coronary Angiography (QCA)
Post-procedure minimum lumen diameter (mm) minus follow-up minimum lumen diameter as determined by quantitative angiography. Minimum lumen diameter is measured within the stent at each time point.
9 months post-index procedure
Secondary Outcomes (1)
Number of Participants With Target Lesion Failure (TLF) at 12 Months Post-index Procedure. TLF is Defined as Any Ischemia-driven Revascularization of the Target Lesion, Myocardial Infarction (Q-wave and Non-Q-wave), or Death Related to the Target Vessel.
12 months post-index procedure
Study Arms (1)
TAXUS Element Stent System
EXPERIMENTALInterventions
TAXUS Element stent implantation
Eligibility Criteria
You may qualify if:
- Subject is ≥ 18 years old
- Eligible for percutaneous coronary intervention (PCI)
- Documented stable angina pectoris (Canadian Cardiovascular Society \[CCS\] Classification 1, 2, 3, or 4) or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia
- Acceptable candidate for coronary artery bypass grafting (CABG)
- Left ventricular ejection fraction (LVEF) is ≥ 30%
- Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
- Subject willing to comply with all specified follow-up evaluations
You may not qualify if:
- Contraindication to aspirin (ASA), or to both clopidogrel and ticlopidine
- Known hypersensitivity to paclitaxel
- Known allergy to stainless steel
- Known allergy to platinum
- Previous treatment of the target vessel with any anti-restenotic drug-coated or drug-eluting coronary stent
- Previous treatment of the target vessel with a bare metal stent (BMS) within 9 months of the index procedure
- Previous treatment of any non-target vessel with any anti-restenotic drug-coated or drug-eluting coronary stent within 9 months of the index procedure
- Previous treatment with intravascular brachytherapy in the target vessel
- Planned PCI or CABG post-index procedure
- Planned or actual target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon or transluminal extraction catheter immediately prior to stent placement
- Myocardial infarction (MI) within 72 hours prior to index procedure
- Cerebrovascular accident (CVA) within the past 6 months
- Cardiogenic shock
- Acute or chronic renal dysfunction
- Prior anaphylactic reaction to contrast agents
- +37 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Medical Center East
Birmingham, Alabama, 35235-3401, United States
Bakersfield Memorial Hospital
Bakersfield, California, 93301, United States
Scripps Clinic
La Jolla, California, 92037, United States
Christiana Hospital
Newark, Delaware, 19718-0002, United States
Mediquest Research at Munroe Regional Medical Center
Ocala, Florida, 34471, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239-2940, United States
St. John's Hospital
Springfield, Illinois, 62701, United States
Northern Indiana Research Alliance / Lutheran Hospital of Indiana
Fort Wayne, Indiana, 46804-4140, United States
Maine Medical Center
Portland, Maine, 04102, United States
Cardiac & Vascular Research Center of Northern Michigan
Petoskey, Michigan, 49770, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407-1195, United States
Nebraska Heart Hospital
Lincoln, Nebraska, 68526, United States
St. Joseph's Hospital Health Center
Liverpool, New York, 13088, United States
Lenox Hill Hospital
New York, New York, 10021, United States
Columbia University Medical Center
New York, New York, 10032, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203-5866, United States
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, 27401, United States
Wake Medical Center
Raleigh, North Carolina, 27610, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157-0001, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214-3907, United States
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, 73120, United States
Main Line Health Heart Center
Bryn Mawr, Pennsylvania, 19010, United States
Methodist DeBakey Heart Center
Houston, Texas, 77030-2767, United States
TexSAn Heart Hospital
San Antonio, Texas, 78229, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Sacred Heart Medical Center
Spokane, Washington, 99204, United States
St. Mary's Medical Center
Huntington, West Virginia, 25701, United States
Related Publications (1)
Allocco DJ, Cannon LA, Britt A, Heil JE, Nersesov A, Wehrenberg S, Dawkins KD, Kereiakes DJ. A prospective evaluation of the safety and efficacy of the TAXUS Element paclitaxel-eluting coronary stent system for the treatment of de novo coronary artery lesions: design and statistical methods of the PERSEUS clinical program. Trials. 2010 Jan 7;11:1. doi: 10.1186/1745-6215-11-1.
PMID: 20059766DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
There were no commercially available dedicated small vessel paclitaxel-eluting stents at the time of study enrollment, thus, the PERSEUS Small Vessel comparator group does not represent the most recently available paclitaxel-eluting stents.
Results Point of Contact
- Title
- Andrey Nersesov, Clinical Project Manager
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Dean J Kereiakes, MD
The Christ Hospital
- PRINCIPAL INVESTIGATOR
Louis A Cannon, MD
Cardiac and Vascular Research Center of Northern Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2007
First Posted
June 21, 2007
Study Start
July 1, 2007
Primary Completion
June 1, 2009
Study Completion
October 1, 2013
Last Updated
May 8, 2014
Results First Posted
June 28, 2011
Record last verified: 2014-04